FDA-Drug2017-06-07Class II
fentaNYL (as citrate) in 0.9% Sodium Chloride injectable,10 mcg per mL, Total Volume 100 mL, Single Dose Container bag, (Total fentanyl Dose 1,000 mcg/100 mL) Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0202-32
SCA Pharmaceuticals
Hazard
Lack of assurance of sterility: Product bags leaking at seam.
Sold states
Nationwide in the USA
Affected count
370 bags
Manufactured in
8821 Knoedl Ct, Little Rock, AR, United States
Products
fentaNYL (as citrate) in 0.9% Sodium Chloride injectable,10 mcg per mL, Total Volume 100 mL, Single Dose Container bag, (Total fentanyl Dose 1,000 mcg/100 mL) Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0202-32
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0873-2017Don't want to check this manually?
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